Evaluation of a urine-based enzyme-linked immunosorbent assay test for the detection of Helicobacter pylori infection among 3- to 5-year-old Israeli Arab healthy children

Abstract

We conducted a community-based study among 159 healthy Israeli Arab children aged 3 to 5 years old to examine the validity of the HpELISA kit (URINELISA, Otuska Phamaceuticals Co, Ltd, Tokyo, Japan) for detection Helicobacter pylori IgG antibodies in urine. The polyclonal H. pylori stool antigen test (Premier HpSA) served as the gold standard. The sensitivity, specificity, positive and negative predictive values of the URINELISA kit were 34.2%, 96.3%, 90% and 60%, respectively. Using a cutoff value calculated based on the receiver operating characteristic curve (0.066), the corresponding figures were 65.8%, 87.5%, 83% and 72%, respectively. These data indicate that the usefulness of the URINELISA test in epidemiological studies in healthy young children is limited.